FDA sets PDUFA date for Alexza's resubmission for Adasuve

8 July 2012

Following two earlier rejections, the US Food and Drug Administration has now accepted Alexza Pharmaceuticals (Nasdaq: ALXA) resubmitted Adasuve (Staccato loxapine). New Drug Application (NDA) as a complete, class 2 response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of December 21, 2012 (The Pharma Letter May 2).

The company’s shares fell 9.8% to $4.26 after-hours trading last Thursday. On June 22, 2012, Alexza announced that it had resubmitted the Adasuve NDA, which seeks marketing approval for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

Adasuve is Alexza's lead program, which is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Alexza completed and announced positive results from both of its Phase II clinical trials and initially submitted the NDA in December 2009.

Partnered with Grupo Ferrer

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK